Actively Recruiting
A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2023-01-13
108
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic(PK) profile of HS-10382 in patients with chronic myeloid leukemia (CML). Anti-CML activity will also be investigated in this study.
CONDITIONS
Official Title
A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Men or women aged 18 years or older and younger than 75 years.
- Diagnosis of chronic myeloid leukemia in chronic phase or accelerated phase with Philadelphia chromosome or BCR-ABL1 fusion genes.
- Resistant or intolerant to previous tyrosine kinase inhibitor (TKI) therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy of at least 12 weeks.
- Use of adequate contraceptive measures during the study; females must not be breastfeeding during the study and for 6 months after completion.
- Females must have evidence of non-childbearing potential.
You will not qualify if you...
- Chronic phase CML patients who have achieved complete cytogenetic response and have not lost it.
- Patients with chronic phase CML who have progressed to accelerated or blast phase.
- Patients with accelerated phase CML who have achieved complete hematologic response or have no evidence of CML in peripheral blood.
- Patients with accelerated phase CML who have progressed to blast phase.
- Previous treatment with a BCR-ABL1 TKI allosteric inhibitor.
- Impaired cardiac function including prolonged QT interval (>470 ms), abnormal ECG rhythms or conduction, risk factors for arrhythmia, left ventricular ejection fraction ≤50%, heart rate <50 bpm during screening, recent myocardial infarction or congestive heart failure within 6 months, or uncontrollable angina.
- History of acute pancreatitis within 1 year or chronic pancreatitis.
- Severe or uncontrolled systemic diseases such as uncontrolled hypertension or diabetes.
- Severe gastrointestinal dysfunction affecting drug absorption.
- Severe infection within 4 weeks prior to first dose.
- History of significant bleeding disorders unrelated to CML.
- Inadequate organ function.
- History of other malignancies.
- History of hypersensitivity to any ingredient of HS-10382.
- History of neuropathy or mental disorders including epilepsy and dementia.
- Investigator judgment of inability to comply with study procedures or requirements.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Y
Yu Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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